Device product

REFLECTION(R), MICROSTABLE(R), ACETABULAR LINER, 20o OVERHANG, 28 MM ID, 54-56 OD, QTY: (1), STERILE EO, REF 71742854, Smith & Nephew, Inc. Memphis, TN 38116 USA. Orthopaedic.

Z-0581-2014

November 25, 2013

Class II

Product summary

Firm: Smith & Nephew Inc
Event: Event 67042
Status: Terminated
Classification: Class II
Quantity: 38 units
Official record key: device-enforcement:Z-0581-2014

Official wording

Reason: One batch of the Reflection(TM) Polyethylene Acetabular Liners may be out of tolerance causing the liner not to fully seat into the shell.

Code information: Batch No. 12BM04836

Distribution pattern: Distributed in China and Spain.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

One batch of the Reflection(TM) Polyethylene Acetabular Liners may be out of tolerance causing the liner not to fully seat into the shell.